Non-erosive Reflux Disease (NERD)
Conditions
Brief summary
The goal of this clinical trial is to learn if inspiratory muscle training (IMT) works to treat on clinical symptom severity and quality of life in patients with Non-erosive reflux disease (NERD). The main questions it aims to answer are: Does drug IMT lower the clinical symptom severity ? Does drug IMT improve quality of life? Researchers will compare high intensity IMT to a sham-IMT (a IMT device with no resistance) to see if IMT lower the clinical symptom severity and improve improve quality of life. Participants will perform the following protocol: The IMT protocol will consist of home-based high-intensity training using a Threshold IMT device: two sets of 30 breaths with a 1-minute rest, twice daily for 4 weeks. The study group will train at 60% of baseline maximum inspiratory pressure (MIP), with weekly adjustments based on modified Borg scores (4-6), while the control group will perform sham IMT without resistance.
Detailed description
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 4 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 4 weeks of training.
Interventions
DEVICEInspiratory Muscle Training (IMT)
The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure, measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.
DEVICESham IMT
The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.
Sponsors
Izmir University of Economics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This study was designed as a prospective and Randomized Controlled experimental study. Participants were randomly divided into two groups in a 1:1 ratio; the study group and the control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of NERD, * No erosive lesions on endoscopy, * Presence of reflux symptoms for at least 3 months.
Exclusion criteria
* Current use of proton pump inhibitors (PPIs) or failure to complete a minimum 2-week washout period before enrollment. * With known gastroduodenal ulcers * Diagnosed with erosive esophagitis * With hiatal hernia * With a history of gastrointestinal malignancy * With infectious or inflammatory gastrointestinal diseases * With malabsorption syndrome or gastrointestinal obstruction * With a history of major gastrointestinal surgery (including anti-reflux, gastric, or duodenal surgery) * With systemic sclerosis or other systemic connective tissue diseases * With severe cardiovascular, pulmonary, renal, or hepatic disease * With chronic respiratory diseases such as asthma or COPD * Having had an acute respiratory tract infection within the past 4 weeks * With neuromuscular diseases * With active tuberculosis * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity | 4 weeks | The Reflux Disease Questionnaire (RDQ) will be used to measure the severity of clinical symptoms. The RDQ is a 12-item self-report scale that assesses the frequency and severity of upper gastrointestinal symptoms over the past week. Each item is rated on a Likert scale from 0 to 5, and the total score is calculated as the average of the relevant items. A higher score indicates more severe symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Muscle Strength | 4 weeks | The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water). |
| Gastroesophageal Reflux Disease-Related Quality of Life | 4 weeks | The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) will be used. The questionnaire will be evaluated based on the total score, with a higher score indicating poorer quality of life. |
| Change in Diagnostic Symptom Score | 4 weeks | The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) will be used to assess changes in diagnostic symptom scores. A high score indicates severe symptoms. |
Countries
Turkey (Türkiye)
Contacts
CONTACTRıdvan Aktan, Assoc Prof.
CONTACTNilay Danış, Assoc Prof.
PRINCIPAL_INVESTIGATORRıdvan Aktan, Assoc Prof.
İzmir University of Economics
Outcome results
None listed